FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3093421
·
Received April 26, 2013
Report
- Report Number
- 1720753-2013-05379
- Event Type
- Malfunction
- Date Received
- April 26, 2013
- Date of Event
- April 17, 2013
- Report Date
- April 26, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ON SITE INVESTIGATION AND PULLED ALL THE LOG FILES. NO CONCLUSION CAN BE DRAWN AS FURTHER REPAIR INFO IS UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM CRASHED (LOCKED-UP) DURING AN EXAM. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 181700 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |